N/A N=55 Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Primary: Conversion of Induced Ventricular Fibrillation — 52 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=189 SJM MRI Diagnostic Imaging Registry (IDE)
Cardiac Arrhythmia
Primary: The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. — 129 MRI Scans
N/A N=994 Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
Tachycardia, Ventricular
Primary: Perioperative S-ICD Complication Free Rate — 983 Participants
N/A N=321 S-ICD® System IDE Clinical Study
Tachycardia, Ventricular
Primary: Percentage of Participants Free of Type I Complications at 180 Days. — 99.0 percentage of participants
N/A N=790 A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
Heart Failure, Systolic · Heart Failure
Primary: Knowledge About Defibrillation at Baseline — 53.4; 55.4 score on a scale
N/A N=1,223 DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.
Death, Sudden, Cardiac · Ventricular Fibrillation · Tachycardia
Primary: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype — 63; 136; 98 participants with VT < 400 msec
N/A N=14 ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
Tachycardia · Ventricular Arrythmia
Primary: Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 2 Weeks Post-implant — 13 Participants
N/A N=53 Same Day Subcutaneous ICD And Send Home (DASH)
Cardiomyopathies · Cardiac Death, Sudden
Primary: Rate of Successful Completion of S-ICD Implantation and Discharge of the Patient on the Same Day the Device is Implanted Using the Analgesia Protocol. — 49 Participants
N/A N=403 Antimicrobial Stewardship Program for Clostridium Difficile Infection.
Clostridium Difficile · Enterocolitis, Pseudomembranous
Primary: Number of Participants With Clostridium Difficile Infection Recurrence. — 34; 21 Participants — p=0.56
N/A N=26 Extravascular ICD Pilot Study
Tachycardia · Ventricular Arrythmia
Primary: Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation — 18 Participants
N/A N=40 Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
Tachycardia · Diabetes Mellitus · Cardiovascular Disease
Primary: All-Cause Mortality — 3; 4 Participants — p=0.354
Phase 3 N=193 Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Anxiety · Depression
Primary: Hospital Anxiety and Depression Scale - Depression Scale at Baseline — 4.70; 7.47; 5.35; 4.12 units on a scale
N/A N=1,766 S-ICD® System Post Approval Study
Primary Prevention of Sudden Cardiac Arrest · Secondary Prevention of Sudden Cardiac Arrest
Primary: Number of Participants Free From Type I Complication — 1869 Participants
N/A N=30 Electronic Device Implantation Through Remote Guidance
Telemedicine · Heart Failure · Defibrillators
Primary: Percentage of Participants With Interventional Procedures Successfully Completed — 10; 20 Participants
N/A N=1,013 Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
Tachycardia
Primary: Patients With Inappropriate Shock(s) — 1.4 Percentage of pts with inap shocks
N/A N=100 Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
Ventricular Fibrillation · Ventricular Tachycardia
Primary: Number of Patients With Skin Symptoms — 0 Participants
Phase 3 N=89 Implantable Cardioverter-Defibrillator Use in the VA System
Cardiomyopathies
Primary: Referral for Implantable Cardioverter Defibrillator — 11; 1 participants
N/A N=155 Philips Intracardiac Echocardiography (ICE) Clinical Registry
Atrial Fibrillation · Stroke · Valve Disease, Heart
Primary: Technical Success — 153 Participants
N/A N=1,820 MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy
Tachycardia · Congestive Heart Failure
Primary: Mortality From Any Cause or First Heart Failure (HF) Event — 901; 543; 188; 188 Participants — p=< 0.001
N/A N=60 China (CN)_Magnetic Resonance Imaging (MRI)_Implantable Cardiac Defibrillator (ICD) [CN_MRI_ICD]
Tachycardia
Primary: Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications — 14; 14; 15; 12 Participants
N/A N=1,500 Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
Primary Prevention of Sudden Cardiac Arrest
Primary: Inappropriate ICD Therapy — 105; 21; 26 participants — p=<0.001
N/A N=6 Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Ventricular Tachyarrhythmias
Primary: Number of Participants With a Successful Induced Ventricular Fibrillation Conversion — 6 Participants
N/A N=48 REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients
Ventricular Tachycardia
Primary: Time to First Event Requiring ICD Therapy or Incessant VT — 177.2; 148.66 days
N/A N=354 DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
Ventricular Tachycardia · Ventricular Fibrillation · Defibrillators, Implantable
Primary: CSAE-score Rate(Clinical Significant Adverse Events Score Rate) — 0.112; 0.128; 0.075 score/month — p=0.0028
N/A N=143 Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
Implantable Cardioverter-Defibrillators
Primary: Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement. — 1 Participants
N/A N=30 Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy
Cardiomyopathy
Primary: Change in Left Ventricular Ejection Fraction — 10.6 percentage of LVEF
Phase 2 N=21 Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
Heart Failure
Primary: Characterize the Technical Feasibility of the Network Based IPC System — 72 percentage of days
Phase 4 N=1,962 RIGHT: Rhythm ID Going Head-to-Head Trial
Tachycardia
Primary: Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge…
N/A N=2,120 SAFEty of Two Strategies of ICD Management at Implantation
Ventricular Fibrillation · Ventricular Flutter · Sudden Cardiac Death
Primary: Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up — 18; 16 Participants
Phase 3 N=1,012 Ranolazine Implantable Cardioverter-Defibrillator Trial
Ischemic Cardiomyopathy · Nonischemic Cardiomyopathy · Heart Failure
Primary: Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death — 174; 198 Participants — p=0.117